晚期胆管癌安罗替尼维持治疗的疗效及安全性分析

Efficacy and safety of anlotinib in maintenance therapy of advanced biliary tract cancer

目的:评估盐酸安罗替尼用于晚期胆管癌一线化疗后维持治疗的疗效及安全性。方法:收集2020年09月至2021年09月期间湖北省十堰市人民医院肿瘤科收治的经一线化疗后疾病评估达到的完全缓解(complete response,CR)、部分缓解(partial response,PR)以及疾病稳定(stable disease,SD)的42例晚期胆管癌患者,一线化疗结束后3周接受盐酸安罗替尼治疗,直至疾病进展。主要研究终点为客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、次要研究终点为无进展生存期(progression-free survival,PFS)、1年总体生存率及安全性。结果:39例患者可进行疗效评估,根据RECIST 1.1标准进行疗效评价:9例患者部分缓解,12例患者疾病稳定,没有患者达到完全缓解,ORR为23.08%,DCR为53.85%,mPFS达到6.0个月(95%CI,4.997~7.003),1年总体生存率69.2%。82.05%的患者报告了不良事件,其中主要不良事件为高血压、手足皮肤反应,无4级以上不良事件发生,没有患者因不良事件而停药。结论:盐酸安罗替尼在晚期胆管癌患者一线化疗后的维持治疗中具有潜在的疗效和可靠的安全性,但需要更大样本量的研究进一步证实。

Objective:To assess the efficacy and safety of anlotinib in maintenance therapy of advanced biliary tract cancer(BTC).Methods:From September 2020 to September 2021,42 patients with advanced biliary carcinoma who had achieved complete response,partial response or stable disease after first-line chemotherapy in the Department of Oncology,Shiyan People's Hospital of Hubei Province were enrolled.They were treated with anlotinib 3 weeks after the end of first-line chemotherapy until disease progression.The primary endpoints were ORR and DCR,and the secondary endpoints were PFS,1-year overall survival rate and safety of anlotinib administration.Results:39 patients could be evaluated according to RECIST 1.1 criteria,9 patients had a partial response,12 had stable disease,and no patients with a complete responses.The ORR was 23.08%,DCR was 53.85%,mPFS reached 6.0 months(4.997~7.003),and the 1-year overall survival rate was 69.2%.82.05%of the patients reported adverse events,the main adverse events were hypertension,hand and foot skin reaction,no grade 4 or higher adverse events occurred,no patients discontinued the drug because of adverse events.Conclusion:Anlotinib demonstrates potential efficacy and tolerable safety in themaintenance therapy for patients with advanced BTC after first-line chemotherapy,and studies with larger sample size are needed to further confirm.